FDA Approves CARBAMAZEPINE — Ingenus Pharmaceuticals, LLC

Ingenus Pharmaceuticals, LLC announced FDA approval of its ANDA for oral carbamazepine tablets, fulfilling the need for a generic alternative to the widely used anticonvulsant branded by Teva CNS USA LLC on March 12, 2024. The approval positions Ingenus to capture a significant portion of the $1.5 billion U.S. market for mood stabilizers, potentially altering competitive dynamics among generic manufacturers in the neurological therapy space.